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Intercept Pharmaceuticals, Inc. - ICPT STOCK NEWS

Welcome to our dedicated page for Intercept Pharmaceuticals news (Ticker: ICPT), a resource for investors and traders seeking the latest updates and insights on Intercept Pharmaceuticals stock.

Intercept Pharmaceuticals, Inc. (ICPT) is a leading biopharmaceutical company dedicated to the development and commercialization of innovative therapeutics aimed at treating progressive, non-viral liver diseases. Intercept's core focus is primarily on conditions such as primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), and biliary atresia. With its headquarters in New York and additional offices in San Diego, London, and Perugia, Intercept is well-positioned globally to drive forward its ambitious healthcare initiatives.

The company's flagship product, Ocaliva® (obeticholic acid), is a farnesoid X receptor (FXR) agonist, approved for the treatment of adults with PBC, either in combination with ursodeoxycholic acid (UDCA) for those with an inadequate response to UDCA or as monotherapy for patients who cannot tolerate UDCA. The recent developments include a landmark Phase 3 POISE trial revealing significant impacts on key biomarkers for PBC treatment, demonstrating Ocaliva's potential to not only reduce gamma-glutamyl transferase (GGT) and alkaline phosphatase (ALP) levels but also improve clinical outcomes.

In addition, Intercept is actively engaged in advancing the investigational combination of OCA and bezafibrate, shown in Phase 2 studies to affect multiple key serum biomarkers predictive of clinical outcomes. This combination therapy targets both FXR and peroxisome proliferator-activated receptor (PPAR) pathways, offering potential enhanced therapeutic benefits.

Financially stable, Intercept continues to invest significantly in R&D, highlighted by recent presentations at the American Association for the Study of Liver Diseases (AASLD) and Digestive Disease Week® (DDW). As of February 2024, the FDA has accepted a supplemental New Drug Application (sNDA) for Ocaliva, further solidifying its position in the liver disease treatment market. Intercept remains committed to improving patient outcomes and enhancing the quality of life for those affected by these serious conditions.

For the most current news and developments, visit the Intercept Pharmaceuticals website or follow their updates on LinkedIn and Twitter.

News

Intercept Pharmaceuticals to Conduct Fireside Chats and One-on-One Meetings at Upcoming Investor Conferences

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Intercept Pharmaceuticals to participate in fireside chats and investor meetings at upcoming conferences
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Intercept Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Business Updates

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Intercept Pharmaceuticals reports Q2 2023 financial results with net sales of $83.7 million, representing 17% growth YoY. The company updates its full-year 2023 net sales guidance to $320-$340 million. Intercept expects to achieve meaningful profitability in 2024. The OCA-bezafibrate combination program shows positive results in Phase 2 studies for the treatment of PBC.
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Intercept to Announce Second Quarter 2023 Financial Results on August 2, 2023

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Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) to announce Q2 2023 financial results on August 2, 2023, with a conference call and webcast. Participants can access the live webcast on the company's investor page and register to ask questions.
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Intercept Announces Restructuring to Strengthen Focus on Rare and Serious Liver Diseases and Significantly Reduce Operating Expenses

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Intercept Presents New Data Showing Significant Impact of OCA-bezafibrate Combination on Normalization of Multiple Biomarkers of PBC-Induced Liver Damage

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Intercept Pharmaceuticals announced new results from a planned interim analysis of its Phase 2 study assessing improvements in serum biomarkers of hepatic function, cholestasis, and inflammation in patients with primary biliary cholangitis (PBC) after treatment with a combination of obeticholic acid (OCA) and bezafibrate. The combination was effective in normalizing multiple biochemical markers associated with PBC-induced liver damage.
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Intercept Receives Complete Response Letter from FDA for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH

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Intercept Announces New Data Showing Potential of Fixed-Dose Combination of OCA and Bezafibrate to Normalize Multiple Biomarkers in PBC to be Featured in Podium Presentation at EASL Congress 2023

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Intercept Pharmaceuticals to Conduct One-on-One Meetings with Investors at the Jefferies Healthcare Conference June 7-8, 2023

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Intercept Announces Outcome of FDA Advisory Committee Meeting for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH

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Intercept Pharmaceuticals received disappointing outcome from the FDA Gastrointestinal Drugs Advisory Committee Meeting regarding the approval of obeticholic acid (OCA) for the treatment of pre-cirrhotic fibrosis due to NASH. Twelve out of 16 voting-eligible members voted against the benefits of OCA, while 15 members voted to defer approval until clinical outcome data from trial 747-303 are submitted and reviewed. Intercept will host a conference call on May 22, 2023, to discuss the meeting.
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Intercept Pharmaceuticals Stock Trading Halted Today; FDA Advisory Committee to Review Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH

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Intercept Pharmaceuticals, Inc. announces trading halt as FDA's Gastrointestinal Drugs Advisory Committee reviews obeticholic acid as a treatment for pre-cirrhotic fibrosis due to NASH. FDA's target action date is June 22, 2023.
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FAQ

What is the market cap of Intercept Pharmaceuticals (ICPT)?

The market cap of Intercept Pharmaceuticals (ICPT) is approximately 794.7M.

What does Intercept Pharmaceuticals, Inc. specialize in?

Intercept Pharmaceuticals, Inc. specializes in the development and commercialization of novel therapeutics to treat progressive, non-viral liver diseases such as primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), and biliary atresia.

What is Ocaliva® (obeticholic acid)?

Ocaliva® (obeticholic acid) is a farnesoid X receptor (FXR) agonist used to treat adults with primary biliary cholangitis (PBC). It can be used in combination with ursodeoxycholic acid (UDCA) for those who have an inadequate response to UDCA or as a monotherapy for those who cannot tolerate UDCA.

Where are Intercept Pharmaceuticals’ offices located?

Intercept Pharmaceuticals’ corporate headquarters are in New York, with additional offices in San Diego, London, and Perugia.

What are the recent developments at Intercept Pharmaceuticals?

Recent developments include Phase 3 POISE trial results demonstrating Ocaliva's potential in improving key biomarkers for PBC treatment and Phase 2 studies exploring the therapeutic benefits of combining OCA with bezafibrate. The FDA also accepted a supplemental New Drug Application (sNDA) for Ocaliva in February 2024.

How does Intercept Pharmaceuticals contribute to liver disease treatment?

Intercept Pharmaceuticals contributes to liver disease treatment through innovative drug development, including Ocaliva® for PBC and investigational combinations like OCA and bezafibrate, targeting progressive non-viral liver diseases and aiming to improve patient outcomes.

What is the significance of the POISE trial?

The POISE trial is significant as it demonstrated Ocaliva's potential to reduce key biomarkers like gamma-glutamyl transferase (GGT) and alkaline phosphatase (ALP) in PBC patients, potentially improving clinical outcomes and survival rates.

What is the investigational combination of OCA and bezafibrate?

The investigational combination of OCA and bezafibrate targets both FXR and peroxisome proliferator-activated receptor (PPAR) pathways, showing potential to enhance therapeutic benefits for PBC patients as evidenced by Phase 2 studies.

How does Intercept Pharmaceuticals stay committed to its mission?

Intercept Pharmaceuticals stays committed to its mission by continuously investing in research and development, presenting new findings in scientific forums, and seeking regulatory approvals to bring innovative treatments to patients with serious liver diseases.

What are the safety concerns associated with Ocaliva?

Ocaliva carries a boxed warning for hepatic decompensation and failure in PBC patients with cirrhosis. Routine monitoring for liver function and potential adverse reactions, including severe pruritus and reduced HDL-C levels, is necessary during treatment.

Where can I find more information about Intercept Pharmaceuticals?

For more information about Intercept Pharmaceuticals, you can visit their website at www.interceptpharma.com or follow their updates on LinkedIn and Twitter.

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Intercept Pharmaceuticals, Inc.

Nasdaq:ICPT

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ICPT Stock Data

794.69M
40.45M
3.13%
81.3%
24.24%
Biotechnology
Healthcare
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United States
Morristown